Molecular Diagnostics

News on lab-developed tests and emerging diagnostic technologies.

FDA Reissues EUA for Fluidigm SARS-CoV-2 Test for Use With Azova Home Collection Kit

Azova's kit is for use with Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free, saliva-based COVID test that previously received EUA.

Eurofins Scientific Posts 17 Percent Increase in FY2020 Revenues

The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.

OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval

The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators.

Bio-Techne Obtains Reimbursement Contract With Humana for Exosome Diagnostics Prostate Biopsy Test

Bio-Techne's CEO said the coverage decision will expand access to its EPI test and enable additional men to better decide whether to proceed with a prostate biopsy.

Hologic Acquires European MDx Firm Diagenode for Approximately $159M

Hologic said that the transaction further strengthens its molecular diagnostics business by expanding its international capabilities, among other benefits.

Mar 01, 2021

Mobidiag SARS-CoV-2, Influenza A/B, RSV Test Receives CE Mark

Feb 26, 2021

GenMark Diagnostics Seeing Continued Demand for Respiratory Panels, Plans 510(k) Submission

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Feb 26, 2021

Natera Launches Tumor Genomic Profiling Assay, Expects Reproductive Health to Break Even This Year

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Feb 26, 2021

Guardant Health Begins First Foray Into Early-Stage Cancer With Commercial MRD Test Launch

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Feb 25, 2021

Natera Revenues Grow 35 Percent in Q4

Feb 25, 2021

GenMark Diagnostics Q4 Revenues Rise 84 Percent on MDx Sales

Feb 25, 2021

CareDx Expanding Diagnostic Tech Into Cell Transplant Monitoring

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Feb 25, 2021

Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch

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Feb 25, 2021

German Nucleic Acid Sample Prep Startup Rides COVID-19 Testing, Automation Waves

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Feb 25, 2021

Luminex Shares Surge on Rumor of Acquisition by DiaSorin

Feb 25, 2021

Personal Genome Diagnostics to Build Commercial Infrastructure, Drive Partnerships With New Funding

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Feb 25, 2021

Oncocyte Closes Second and Final Investment in Razor Genomics Acquisition

Feb 25, 2021

Biocartis Reports 15 Percent Rise in 2020 Revenues

Feb 25, 2021

Novacyt Obtains CE Mark for Extraction-Free COVID-19 PCR Test

Feb 24, 2021

Guardant Health Q4 Revenues Up 25 Percent

Feb 24, 2021

Adaptive Biotechnologies Q4 Revenues Rise 25 Percent

Feb 24, 2021

CareDx Q4 Revenues Up 64 Percent

Feb 24, 2021

ACMG Lobbying State Legislatures on Genetic Counselors' Scope of Practice Draws Criticism

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Feb 24, 2021

Walgreens to Sell Labcorp COVID-19 PCR Home Collection Kits Over-the-Counter

Feb 24, 2021

Qiagen, Inovio Expand CDx Partnership, Starting With NGS Test for Cervical Dysplasia Therapy

The Scan

More Details Wanted

Nature News writes that additional details about the UK plan for an agency to support high-risk, high-reward science are needed.

And a Third

The New York Times reports that the US Food and Drug Administration has authorized Johnson & Johnson's SARS-CoV-2 vaccine.

Glimpses of Viral Origins

The Wall Street Journal writes new studies are giving glimpses into the origins of SARS-CoV-2.

PLOS Papers on Plasmodium Falciparum Populations, Scabies Molecular Diagnostics, More

In PLOS this week: analysis of Plasmodium population structure, qPCR assay to diagnose scabies, and more.

Featured White Papers

Congenica Enables Five Minute Diagnosis of Previously Unsolved Case

Congenica CNV Calling for Exomes Whitepaper

Congenica Splice Site Finder White Paper

Expediting an Accurate Diagnosis through Streamlined Clinical Workflows

Mar

11

Featured Webinar

Virtual Molecular Tumor Board Series: Gene Fusions as Druggable Targets

In this session, the third in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling has identified gene fusions that may or may not serve as druggable targets.

Mar

16

Featured Webinar

The Predictive Power of Poop: COVID-19 Wastewater Surveillance to Inform Public Health Decisions in Colorado

Wastewater based epidemiology (WBE) has been established as a viable, valuable, and cost-effective means to monitor infectious disease within a community.

Mar

17

Featured Webinar

Spatial Profiling of Metabolic Regulation in the Human Tumor Microenvironment Using Multiplexed Ion Beam Imaging

In this webinar, Felix J. Hartmann of Stanford University will describe an approach that characterizes the metabolic regulome of individual cells together with their phenotypic identity.

Mar

18

Featured Webinar

Molecular Multi-Target Assay Design Coupled with Reflex Testing with SARS-CoV-2 Mutations in Mind

Viruses mutate as they strive to thrive in response to selective pressures.

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